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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name transcutaneous nerve stimulator for adhd
De Novo Number DEN180041
Device Name Monarch eTNS System
NeuroSigma, Inc
10960 wilshire boulevard
suite 1910
los angeles,  CA  90024
Contact ian a. cook
Regulation Number882.5898
Classification Product Code
Date Received07/30/2018
Decision Date 04/19/2019
Decision granted (DENG)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct